Trial · NCT01024920
Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.
NCT01024920, Phase 2, Completed, Boehringer Ingelheim; results first posted 2020-06-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib. Trials, record NCT01024920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01024920
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.
- NCT number
- NCT01024920
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 99 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Carcinoma, Renal Cell
- Interventions
- BIBF 1120, sunitinib
- First posted
- 2009-12-03
- Last updated
- 2021-07-19
- Other registries' IDs
- eudract:2009-009516-44
- Results first posted
- 2020-06-17
Source ClinicalTrials.gov
Registered outcomes43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Probability Rates of Progression-free Survival at 9 Months | At 9 months after randomisation. | Progression free survival rate at 9 months is the estimated probability of being alive and not having progressive disease at 9 months after randomisation. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria version 1.1 (RECIST v1.1), at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started together with an absolute increase in the sum of the longest diameters of at least 5 mm, or the appearance of one or more new lesions. Tumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication. |
| Primary | Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) | At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15. | QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate by the Fridericia formula. Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 15 in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 15 obtained at time t minus baseline QTcF measurement at time t. 0 h is 5 min prior to dosing on Day 15. Time-matched change from baseline to Day 15 in QTcF was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 0 h,1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib on Day 15 of are reported. |
| Secondary | Progression Free Survival (PFS) | From the start of study until the cut-off date for 3 year efficacy analysis, up to 3 years. | Progression free survival (PFS) from randomisation to the occurrence of disease progression (by RECIST Version 1.1) or death, whichever occurred first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started together with an absolute increase in the sum of the longest diameters of at least 5 mm, or the appearance of one or more new lesions. Tumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication. The Kaplan-Meier method was used to calculate the estimates. |
| Secondary | Objective Response According to RECIST Criteria | From the start of study until the cut-off date for 3 year efficacy analysis, up to 3 years. | Objective response was defined as complete response (CR, the disappearance of all target and non-target lesions and no new lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of the longest diameters and no new lesions) as determined by RECIST Version 1.1. Numbers of participants with objective response are reported. Tumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication. |
| Secondary | Duration of Objective Response | From the time of first objective response to the time of disease progression or death (whichever comes first), up to 3 years. | Duration (months) of objective response was measured from the time of first objective response to the time of disease progression (by RECIST Version 1.1) or death, whichever occurred first. Objective response was defined as complete response (CR, the disappearance of all target and non-target lesions and no new lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of the longest diameters and no new lesions) as determined by RECIST Version 1.1. Tumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication. The Kaplan-Meier method was used to calculate the estimates. |
| Secondary | Overall Survival | From randomisation to death, up to 3 years. | Overall survival was calculated as the time (months) from randomisation to death. Patients for whom there was no evidence of death at the time of analysis were censored on the date that they were last known to have been alive. The Kaplan-Meier method was used to calculate the estimates. |
| Secondary | Time to Progression | From randomisation up to objective tumour progression, up to 3 years. | Time to progression is defined as the time period from randomisation to objective tumour progression. Patients with no progression (by RECIST Version 1.1) were censored at the date of the last evaluable imaging. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started together with an absolute increase in the sum of the longest diameters of at least 5 mm, or the appearance of one or more new lesions. Tumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication. The Kaplan-Meier method was used to calculate the estimates. |
| Secondary | Time to Treatment Failure | From randomisation up to objective tumour progression, up to 3 years. | Time to treatment failure was defined as the time from randomisation to objective tumour progression (by RECIST Version 1.1), death, global deterioration of health status requiring treatment discontinuation, or start of new anticancer treatment, whichever came first. Tumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication.The Kaplan-Meier method was used to calculate the estimates. |
| Secondary | Time-matched Change From Baseline to Day 1 in QTcF (QT Interval Corrected by the Fridericia Formula) at 1 Hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) | At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 of treatment Cycle 1. Baseline (Day -1) values were taken at exactly the same time points as on Day 1. | QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate by the Fridericia formula. Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 1 obtained at time t minus baseline QTcF measurement at time t. Time-matched change from baseline to Day 1 in QTcF was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib on Day 1 are reported. |
| Secondary | Time-matched Change From Baseline in QTcF Interval (QT Interval Corrected by the Fridericia Formula) at the Time of Each Participant's Maximum Plasma Concentration of Nintedanib (BIBF 1120), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 | At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description. | QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula. Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline QTcF measurement at time t. For each participant 'Time-matched change from baseline to Day 1 (Day 15) in QTcF' at the time of the participant's maximum nintedanib plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported. Time frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15. |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 registered outcomesOutcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Probability Rates of Progression-free Survival at 9 Months | At 9 months after randomisation. | Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment. | Probability | NUMBER |
| PRIMARY | Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) | At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15. | Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex (Q, R and S wave) to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis. | milliseconds (ms) | LEAST_SQUARES_MEAN |
| SECONDARY | Progression Free Survival (PFS) | From the start of study until the cut-off date for 3 year efficacy analysis, up to 3 years. | Treated set: all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment. | Months | MEDIAN |
| SECONDARY | Objective Response According to RECIST Criteria | From the start of study until the cut-off date for 3 year efficacy analysis, up to 3 years. | Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Objective Response | From the time of first objective response to the time of disease progression or death (whichever comes first), up to 3 years. | Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment and showed objective response. | Months | MEDIAN |
| SECONDARY | Overall Survival | From randomisation to death, up to 3 years. | Treated Set (TS) : All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment. | Months | MEDIAN |
| SECONDARY | Time to Progression | From randomisation up to objective tumour progression, up to 3 years. | Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment. | Months | MEDIAN |
| SECONDARY | Time to Treatment Failure | From randomisation up to objective tumour progression, up to 3 years. | Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment. | Month | MEDIAN |
| SECONDARY | Time-matched Change From Baseline to Day 1 in QTcF (QT Interval Corrected by the Fridericia Formula) at 1 Hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) | At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 of treatment Cycle 1. Baseline (Day -1) values were taken at exactly the same time points as on Day 1. | Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis. | milliseconds (ms) | LEAST_SQUARES_MEAN |
| SECONDARY | Time-matched Change From Baseline in QTcF Interval (QT Interval Corrected by the Fridericia Formula) at the Time of Each Participant's Maximum Plasma Concentration of Nintedanib (BIBF 1120), Calculated Separately for Days 1 and 15 of Treatment Cycle 1 | At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description. | Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis. | milliseconds (ms) | MEAN |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 outcomesResults by group289
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Probability Rates of Progression-free Survival at 9 Months | Nintedanib (BIBF 1120) | 0.431 | 95% Confidence Interval 0.306 to 0.550 | Probability | |
| Probability Rates of Progression-free Survival at 9 Months | Sunitinib | 0.452 | 95% Confidence Interval 0.274 to 0.614 | Probability | |
Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) | Nintedanib (BIBF 1120) | Time-matched change from baseline to Day 15 at -5 minutes (min) | 2.6 | 90% Confidence Interval -0.7 to 5.9 | milliseconds (ms) |
Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) | Nintedanib (BIBF 1120) | Time-matched change from baseline to Day 15 at 1 hour (h) | 0.4 | 90% Confidence Interval -2.8 to 3.7 | milliseconds (ms) |
Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) | Nintedanib (BIBF 1120) | Time-matched change from baseline to Day 15 at 2 h | -1.7 | 90% Confidence Interval -4.9 to 1.6 | milliseconds (ms) |
Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) | Nintedanib (BIBF 1120) | Time-matched change from baseline to Day 15 at 3 h | -0.5 | 90% Confidence Interval -3.8 to 2.8 | milliseconds (ms) |
Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) | Nintedanib (BIBF 1120) | Time-matched change from baseline to Day 15 at 4 h | -0.5 | 90% Confidence Interval -3.8 to 2.8 | milliseconds (ms) |
Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) | Nintedanib (BIBF 1120) | Time-matched change from baseline to Day 15 at 5 h | 0.3 | 90% Confidence Interval -3.0 to 3.6 | milliseconds (ms) |
Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) | Nintedanib (BIBF 1120) | Time-matched change from baseline to Day 15 at 6 h | 2.2 | 90% Confidence Interval -1.1 to 5.5 | milliseconds (ms) |
Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120) | Nintedanib (BIBF 1120) | Time-matched change from baseline to Day 15 at 7 h | 3.1 | 90% Confidence Interval -0.2 to 6.4 | milliseconds (ms) |
1 to 10 of 289Source ClinicalTrials.gov
See all 289 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nintedanib (BIBF 1120) | 67 | |
| Overall Study | STARTED | Sunitinib | 32 | |
| Overall Study | Treated | Nintedanib (BIBF 1120) | 64 | |
| Overall Study | Treated | Sunitinib | 32 | |
| Overall Study | COMPLETED | Nintedanib (BIBF 1120) | 0 | |
| Overall Study | COMPLETED | Sunitinib | 0 | |
| Overall Study | NOT COMPLETED | Nintedanib (BIBF 1120) | 67 | |
| Overall Study | NOT COMPLETED | Sunitinib | 32 |
Source ClinicalTrials.gov
Adverse events188
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Nintedanib (BIBF 1120) | 4 | 64 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib | 5 | 32 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nintedanib (BIBF 1120) | 0 | 64 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib | 3 | 32 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nintedanib (BIBF 1120) | 0 | 64 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sunitinib | 2 | 32 | |
| other | Hyperthyroidism | Endocrine disorders | Nintedanib (BIBF 1120) | 1 | 64 | |
| other | Hyperthyroidism | Endocrine disorders | Sunitinib | 2 | 32 | |
| other | Hypothyroidism | Endocrine disorders | Nintedanib (BIBF 1120) | 2 | 64 | |
| other | Hypothyroidism | Endocrine disorders | Sunitinib | 5 | 32 |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nintedanib (BIBF 1120) | 50 | 64 |
| Total, all-cause mortality | Sunitinib | 25 | 32 |
| Total, other adverse events | Nintedanib (BIBF 1120) | 55 | 64 |
| Total, other adverse events | Sunitinib | 27 | 32 |
| Total, serious adverse events | Nintedanib (BIBF 1120) | 20 | 64 |
| Total, serious adverse events | Sunitinib | 11 | 32 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nintedanib (BIBF 1120) vs Sunitinib: Number of Participants With Adverse Events Leading to Dose Reduction | Trial comparisons |
| Nintedanib (BIBF 1120) vs Sunitinib: Number of Participants With Adverse Events Leading to Discontinuation of Trial Drug | Trial comparisons |
| Nintedanib (BIBF 1120) vs Sunitinib: deaths from any cause | Trial comparisons |
| Nintedanib (BIBF 1120) vs Sunitinib: Number of Participants With Adverse Events Requiring or Prolonging Hospitalisation | Trial comparisons |
| Nintedanib (BIBF 1120) vs Sunitinib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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